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adverse reactions
ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ENTOCORT EC was evaluated in 651 patients in five short-term, active disease state studies. They ranged in age from 17 to 74 (mean 35), 40% were male and 97% were white, 2.6% were ≥65 years of age. Five hundred and twenty patients were treated with ENTOCORT EC 9 mg (total daily dose). In general, ENTOCORT EC was well tolerated in these trials. The most common adverse events reported were headache, respiratory infection, nausea, and symptoms of hypercorticism. Clinical studies have shown that the frequency of glucocorticosteroid-associated adverse events was substantially reduced with ENTOCORT EC capsules compared with prednisolone at therapeutically equivalent doses. Adverse events occurring in ≥ 5% of the patients are listed in Table 2: Table 2 Adverse Events Occurring in ≥5% of the Patients in any Treated Group ENTOCORT EC 9 mg n=520 Placebo n=107 Prednisolone 40 mg n=145 Comparator This drug is not approved for the treatment of Crohn's disease in the United States n=88 Adverse Event Number (%) Number (%) Number (%) Number (%) Headache 107 (21) 19 (18) 31 (21) 11 (13) Respiratory Infection 55 (11) 7 (7) 20 (14) 5 (6) Nausea 57 (11) 10 (9) 18 (12) 7 (8) Back Pain 36 (7) 10 (9) 17 (12) 5 (6) Dyspepsia 31 (6) 4 (4) 17 (12) 3 (3) Dizziness 38 (7) 5 (5) 18 (12) 5 (6) Abdominal Pain 32 (6) 18 (17) 6 (4) 10 (11) Flatulence 30 (6) 6 (6) 12 (8) 5 (6) Vomiting 29 (6) 6 (6) 6 (4) 6 (7) Fatigue 25 (5) 8 (7) 11 (8) 0 (0) Pain 24 (5) 8 (7) 17 (12) 2 (2) The safety of ENTOCORT EC was evaluated in 233 patients in four long-term clinical trials (52 weeks). A total of 145 patients were treated with ENTOCORT EC 6 mg. A total of 8% of ENTOCORT EC patients discontinued treatment due to adverse events compared with 10% in the placebo group. The adverse event profile in long-term treatment of Crohn’s disease was similar to that of short-term treatment with ENTOCORT EC 9 mg in active Crohn’s disease. In the long-term clinical trials, the following adverse events occurred in ≥ 5% of the 6 mg ENTOCORT EC patients and are not listed in Table 2 or by body system below: diarrhea (10%); sinusitis (8%); infection viral (6%); and arthralgia (5%). Adverse events occurring in 520 patients treated with ENTOCORT EC 9 mg (total daily dose) in five short-term, active disease state studies. with an incidence <5% and greater than placebo (n=107) are listed below by body system: Body as a Whole: asthenia, C-Reactive protein increased, chest pain, dependent edema, face edema, flu-like disorder, malaise; Cardiovascular: hypertension; Central and Peripheral Nervous System: hyperkinesia, paresthesia, tremor, vertigo; Gastrointestinal: anus disorder, Crohn’s disease aggravated, enteritis, epigastric pain, gastrointestinal fistula, glossitis, hemorrhoids, intestinal obstruction, tongue edema, tooth disorder; Hearing and Vestibular: Ear infection-not otherwise specified; Heart Rate and Rhythm: palpitation, tachycardia; Metabolic and Nutritional: hypokalemia, weight increase; Musculoskeletal: arthritis aggravated, cramps, myalgia; Psychiatric: agitation, appetite increased, confusion, insomnia, nervousness, sleep disorder, somnolence; Resistance Mechanism: moniliasis; Reproductive, Female: intermenstrual bleeding, menstrual disorder; Respiratory: bronchitis, dyspnea; Skin and Appendages: acne, alopecia, dermatitis, eczema, skin disorder, sweating increased; Urinary: dysuria, micturition frequency, nocturia; Vascular: flushing; Vision: eye abnormality, vision abnormal; White Blood Cell: leukocytosis For the 145 patients treated with ENTOCORT EC 6 mg (total daily dose) in long-term studies, the following adverse events that are not included in the list above occurred with an incidence <5% but >2% and greater than for placebo: abscess, amnesia, dizziness, fever, pharynx disorder, purpura, rhinitis, and urinary tract infection. Glucocorticosteroid Adverse Reactions Table 3 displays the frequency and incidence of signs/symptoms of hypercorticism by active questioning of patients in short-term clinical trials. Table 3Summary and Incidence of Signs/Symptoms of Hypercorticism in Short-Term Studies ENTOCORT EC 9 mg n=427 Placebo n=107 Prednisolone Taper 40 mg n=145 Signs/Symptom Number (%) Number (%) Number (%) Acne 63 (15) 14 (13) 33 (23) Statistically significantly different from ENTOCORT EC 9 mg Bruising Easily 63 (15) 12 (11) 13 (9) Moon Face 46 (11) 4 (4) 53 (37) Swollen Ankles 32 (7) 6 (6) 13 (9) Hirsutism Adverse event dictionary included term hair growth increased, local and hair growth increased, general. 22 (5) 2 (2) 5 (3) Buffalo Hump 6 (1) 2 (2) 5 (3) Skin Striae 4 (1) 2 (2) 0 (0) Table 4 displays the frequency and incidence of signs/symptoms of hypercorticism by active questioning of patients in long-term clinical trials. Table 4: Summary and Incidence of Signs/Symptoms of Hypercorticism in Long-Term Studies ENTOCORT EC 3 mg n-88 ENTOCORT EC 6 mg n=145 Placebo n=143 Signs/Symptom Number (%) Number (%) Number (%) Bruising Easily Acne Moon Face Hirsutism Swollen Ankles Buffalo Hump Skin Striae 4 (5) 4 (5) 3 (3) 2 (2) 2 (2) 1 (1) 2 (2) 15 (10) 14 (10) 6 (4) 5 (3) 3 (2) 1 (1) 0 5 (4) 3 (2) 0 1 (1) 3 (2) 0 0 The incidence of signs/symptoms of hypercorticism as described above in long-term clinical trials was similar to that seen in the short-term clinical trials. A randomized, open, parallel-group multicenter safety study specifically compared the effect of ENTOCORT EC (<9 mg/day) and prednisolone (<40 mg/day) on bone mineral density over 2 years when used at doses adjusted to disease severity. Bone mineral density decreased significantly less with ENTOCORT EC than with prednisolone in steroid-naïve patients, whereas no difference could be detected between treatment groups for steroid-dependent patients and previous steroid users. The incidence of treatment-emergent symptoms of hypercorticism was significantly higher with prednisolone treatment. Postmarketing Experience The following adverse reactions have been identified during postapproval use of ENTOCORT EC. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune System Disorders : Anaphylactic reactions; Nervous System Disorders : Benign intracranial hypertension.